Label: MUCUS RELIEF DM- dextromethorphan hbr/guaifenesin tablet

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph final

DISCLAIMER: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

Drug Label Information

Updated May 21, 2019

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  • ACTIVE INGREDIENT

    Each immediate-release tablet contains

    Dextromethorphan HBr 20 mg Guaifenesin 400 mg

  • INACTIVE INGREDIENT

    Colloidal Silicon Dioxide, Magnesium Stearate, Maltodextrin, Microcrystalline Cellulose, Povidone, Silicon Dioxide, Sodium Starch Glycolate, Stearic Acid

  • PURPOSE

    Expectorant – Cough Suppressant

  • INDICATIONS & USAGE

    Helps loosen phlegm (mucus)

    Helps thin bronchial secretions to make coughs more productive

    Temporarily relieves cough due to minor throat and bronchial irritation associated with the common cold

  • DOSAGE & ADMINISTRATION

    Directions: Adults and children 12 years of age and older, take 1 tablet every 4 hours with a full glass of water while symptoms persist. Do not exceed 6 doses in 24 hours.

    Children under 12 years of age do not use.

  • WARNINGS

    WARNINGS: Do not use if you are now taking a prescription monoamine oxidase inhibitor (MAOI) (certain drugs for depression, psychiatric, or emotional conditions, or Parkinson’s disease), or for 2 weeks after stopping the MAOI drug. If you do not know if your prescription drug contains an MAOI, ask a doctor or pharmacist before taking this product.

  • KEEP OUT OF REACH OF CHILDREN

    Keep Out of Reach of Children: In case of overdose, get medical help or contact a Poison Control Center

  • PRINCIPAL DISPLAY PANEL

    30ct

  • INGREDIENTS AND APPEARANCE
    MUCUS RELIEF DM 
    dextromethorphan hbr/guaifenesin tablet
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:41226-280
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS) DEXTROMETHORPHAN HYDROBROMIDE20 mg
    GUAIFENESIN (UNII: 495W7451VQ) (GUAIFENESIN - UNII:495W7451VQ) GUAIFENESIN400 mg
    Inactive Ingredients
    Ingredient NameStrength
    SODIUM STARCH GLYCOLATE TYPE A POTATO (UNII: 5856J3G2A2)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    MALTODEXTRIN (UNII: 7CVR7L4A2D)  
    MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
    POVIDONE (UNII: FZ989GH94E)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    Product Characteristics
    ColorwhiteScoreno score
    ShapeOVALSize10mm
    FlavorImprint Code TCL280
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:41226-280-0330 in 1 BOTTLE; Type 0: Not a Combination Product06/03/2019
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34106/03/2019
    Labeler - KROGER COMPANY (006999528)
    Registrant - TIME CAP LABORATORIES, INC (037052099)
    Establishment
    NameAddressID/FEIBusiness Operations
    TIME CAP LABORATORIES, INC037052099manufacture(41226-280)
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